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. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Riest 2008.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 160
Country: Germany
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: morphine PCA
Pain score collection: trained nurse
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Discectomy

  2. Aged 18‐88 years old


Exclusion criteria
  1. Mental or physical inability to handle a PCA

  2. ASA > 3

  3. Preoperative opioids

  4. Administration of steroids or NSAIDs within 24 hours before skin incision

  5. Allergy against sulphonamides or NSAIDs

  6. Severe liver dysfunction

  7. Congestive heart failure

  8. History of myocardial infarction

  9. Stroke

  10. Pulmonary embolism

  11. Gastrointestinal bleeding

  12. Refusal

  13. Pregnancy and/or lactation

Interventions Group Perioperative (80 participants): 40 mg IV parecoxib 45 minutes before surgery and 12 and 24 hours after surgery
Group Postoperative (80 participants): placebo 45 minutes before surgery and 12 and 24 hours after surgery
Outcomes
  1. Postoperative pain (average pain score over 24 hours using 0‐10 VRS and BPI)

  2. Morphine consumption (mg at 25 hours)

  3. Opioid adverse events (using SDS at 25 hours)

  4. Adverse events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis or gastrointestinal bleeding during follow‐up)

Notes Funding: "Investigator initiated trial funded by Pfizer, Germany. Pfizer did not participate in generation of the study design or interpretation of results".
Declarations of interest: as above
Authors contacted: no
Other: unable to include opioid adverse events as not individually reported. Pain not included as average used
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "...randomization with a computer‐generated random list"
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias)
All outcomes High risk Many patients excluded but unclear to which groups they belonged. Quote: "43 patients were excluded before assessment of the primary criteria for the following reasons..."
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Unclear risk No baseline characteristics table. Industry funded but stated no involvement in study